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HHS Awards MedImmune Contract to Manufacture Live Attenuated Nasal Spray Vaccine for Novel Influenza A (H1N1)
Date:6/1/2009

MedImmune Plans to Begin Shipping Seasonal Vaccine to Health Care Providers in August

GAITHERSBURG, Md., June 1 /PRNewswire/ -- MedImmune announced today that the U.S. Department of Health and Human Services (HHS) has awarded the company a contract to manufacture monovalent (single-strain) live attenuated influenza vaccine for Novel Influenza A (H1N1) to vaccinate priority populations identified by HHS in the National Strategy for Pandemic Influenza. An initial order of $90 million of vaccine has been placed, with the potential for additional orders. This project has been funded in whole or in part with the Federal funds from HHS/ASPR/BARDA, under Contract No. HHSO100200900002I.

MedImmune scientists have identified several promising vaccine candidates against the Novel Influenza A (H1N1) strain, and are currently evaluating their growth properties and antigenicity (i.e., their ability to stimulate antibodies) for mass production as part of the vaccine manufacturing process.

"MedImmune is pleased to be able to contribute our scientific expertise in influenza vaccine development and manufacturing to help combat this unpredictable public health threat," said Ben Machielse, Drs., executive vice president of operations, MedImmune. "We are confident that our vaccine technology has several attributes that may be useful in protecting people with limited exposure to influenza against the Novel Influenza A (H1N1) strain."

MedImmune's live attenuated influenza vaccine (LAIV) technology may be particularly well-suited for vaccinating against emerging influenza strains. LAIV is different from the injectable influenza vaccine ("flu shot") in that it is a gentle mist sprayed into the nose, where the influenza virus usually enters the body. It contains live vaccine virus strains that are weakened so as not to cause the flu, but prompt the body to mount an immune response after the first dose. Because it is live and stimulates a broad range of immune responses, LAIV may offer some cross-protection against circulating flu strains that are "drifted" - meaning they are very closely-related but not perfectly matched to the flu strains in the vaccine.

As a needle-free nasal spray, LAIV is well suited to facilitate mass vaccination, and has been widely used for school-based vaccinations and to help protect active-duty military personnel.

While MedImmune is committed to supporting global efforts to help protect individuals against the Novel Influenza A (H1N1) virus, its vaccine technology is currently only licensed in the United States. MedImmune is willing to make additional vaccine available to other governments if any capacity remains after fulfilling obligations to the U.S. government, assuming that necessary regulatory approval can be obtained.

Seasonal FluMist(R) on Track to Begin Shipping in August

MedImmune believes that the best way to help protect all eligible age groups against seasonal influenza is to vaccinate prior to and during the back-to-school period. The CDC's Advisory Committee on Immunization Practices (ACIP) recommends influenza vaccination for all age groups as soon as seasonal vaccine is available each year. MedImmune plans to begin shipping the first of approximately 10 million doses of seasonal FluMist(R) (Influenza Virus Vaccine Live, Intranasal) to health care providers in August. This early availability of vaccine significantly widens the window of opportunity to vaccinate more eligible individuals and improve seasonal influenza vaccination rates, as patients seeing their providers for routine office visits can be vaccinated without waiting for the rush of fall vaccination clinics.

About Seasonal FluMist

FluMist(R) (Influenza Virus Vaccine Live, Intranasal) is a vaccine indicated for active immunization of individuals two to 49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

FluMist is contraindicated in individuals with history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine or with life- threatening reactions to previous influenza vaccinations, and in children and adolescents receiving concomitant aspirin or aspirin-containing therapy.

Do not administer FluMist to children less than two years of age due to an increased risk of hospitalization and wheezing that was observed in clinical trials. FluMist should not be administered to any individual with asthma and to children less than five years of age with recurrent wheezing unless the potential benefit outweighs the potential risk. Do not administer FluMist to individuals with severe asthma or active wheezing.

If Guillain-Barre syndrome has occurred with prior influenza vaccination or if an individual is immunocompromised, the decision to give FluMist should be based on careful consideration of the potential benefits and risks. FluMist should not be administered to individuals with underlying medical conditions predisposing them to wild-type influenza infection complications unless the potential benefit outweighs the potential risk. FluMist should be given to a pregnant woman only if clearly needed.

Most common adverse reactions (occurring in 10 percent or more of individuals receiving FluMist and at a rate at least five percent higher than in those receiving placebo) are runny nose or nasal congestion in recipients of all ages, fever more than 100 degrees F in children two to six years of age, and sore throat in adults.

FluMist may not protect all individuals receiving the vaccine. FluMist is for intranasal administration only.

Please see complete Prescribing Information for FluMist, call 1-877-FLUMIST (1-877-358-6478) or visit http://www.flumist.com/prescribing-information.aspx for additional information.

About MedImmune

MedImmune, the worldwide biologics business for AstraZeneca PLC (LSE: AZN.L, NYSE: AZN), has approximately 3,100 employees worldwide and is headquartered in Gaithersburg, Maryland. With an advancing pipeline of promising candidates, we aim to be the next revolutionary force in biotechnology by delivering life-changing products, industry-leading performance, and a tireless commitment to improving patient health. For more information, visit MedImmune's website at www.medimmune.com.

The opinions expressed herein do not represent opinions or statements made or expressed by the U.S. Department of Health and Human Services.

http://www.medimmune.com


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